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FDA: Aegerion reaches settlement over misbranding of lomitapide
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Aegerion Pharmaceuticals agreed to plead guilty to two misdemeanor counts of violating the Federal Food, Drug and Cosmetic Act, which involved the misbranding of lomitapide, a treatment for homozygous familial hypercholesterolemia, according to a news release from the FDA.
As part of the agreement, Aegerion has agreed to pay $40 million, a company spokesperson confirmed to Cardiology Today.
Insufficient label information
The misbranding of lomitapide (Juxtapid) was caused by noncompliance of the Risk Evaluation and Mitigation Strategy (REMS) program in addition to inadequate label information on all of its intended uses, according to the release.
“By failing to follow the safety requirements that Aegerion had agreed to, the company put patients’ lives at risk and didn’t honor the safety commitments they made as a condition of gaining approval for their drug,” Scott Gottlieb, MD, FDA commissioner, said in the news release. “This is unacceptable. We will continue to pursue those who skirt the law and flout patient safety and other post-market commitments, using all of the enforcement tools available to us. Post-market safety requirements are a key element of the FDA’s public health protections, and we will ensure that they are fulfilled.”
The agreement is a resolution to a criminal investigation, in which the FDA’s Office of Criminal Investigations participated.
“We worked closely with the government to achieve these settlements and believe they are fair and are in the best interest of our stakeholders,” Amanda Murphy, associate director of investor relations and public relations for Aegerion Pharmaceuticals, told Cardiology Today. “These resolutions help minimize the time and expense devoted to the investigations, allow Aegerion to satisfy the [Department of Justice’s] and [Securities and Exchange Commission’s] concerns with the historical conduct and permit Aegerion to operate appropriately moving forward.”
Although lomitapide was approved for the treatment of homozygous familial hypercholesterolemia, Aegerion represented the diagnosis of the condition in a vague manner to increase the number of patient populations that can be treated with the medication, the FDA stated in its release.
According to the agency, a misleading REMS assessment report was filed by Aegerion, stating that lomitapide was distributed with a definition of familial hypercholesterolemia that conflicted with pre-approval filings with the FDA.
The FDA also stated that the company’s “management and sales personnel distributed Juxtapid not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.”
Agreements with FDA, United States
Aegerion and Charles M. Gerrits, PharmD, PhD, one of its senior vice presidents, agreed to enter a consent decree of permanent injunction with the United States, which includes legal tools and a comprehensive compliance program to ensure compliance with the law, according to the FDA release.
“Aegerion is committed to a culture of integrity, transparency and ethics,” Mary Szela, CEO of Novelion Therapeutics, the parent company of Aegerion, wrote in a letter on the company’s website. “We have made enhancements to strengthen our compliance efforts, including the appointment of a new executive team, board of directors and the implementation of a new code of conduct. As a company, we are deeply committed to legal and regulatory compliance and remaining in good standing with not only the government, but with the patients, physicians and other stakeholders with whom we interact.”
The $40 million from the settlement covers various agreements, which included criminal fines and forfeiture and reimbursement to state and federal health care programs, Szela stated in her letter.
Murphy told Cardiology Today that “there are no changes to our marketing of Juxtapid.”– by Darlene Dobkowski
Disclosures: Gerrits and Murphy are employees of Aegerion Pharmaceuticals. Szela is an employee of Novelion Therapeutics.
Perspective
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Sergio Fazio, MD, PhD
Both lomitapide and mipomersen (Kynamro, Genzyme/Ionis) are drugs at risk of being misused by non-experts, since the definition of homozygous familial hypercholesterolemia (HoFH) does not need to be obtained at the genetic level.
The prevalence of real HoFH is very low and likely less than 500 patients should be in the U.S. today with this condition. So if there were more patients treated than the expected number of affected patients, then misuse can be suspected. Obviously, intentional misbranding or inappropriate positioning of the drug would make the misuse more egregious, and illegal.
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